The Impact Of Government Regulation On Health Care Technology

Increased government regulation of the medical device industry produces higher expenses, a longer time to return investment capital, and greater uncertainty. As a result there are fewer new ventures and reduced efforts to develop new technology in established companies. The current federal regulatory framework has shifted from monitoring the product to monitoring the process. The inability to reach perfect performance in a such a regulated environment subject to continuous and fluid interpretation guarantees non-compliance and growing ethical tension. Without new medical technology, we may be unable to maintain quality medical coverage in the face of rising demand. The author proposes risk assessment to set regulatory priorities; the conversion of a national weapons lab to a national device testing lab; the establishment of device standards and the monitoring of in-use performance against these standards; and the education of patients and users as to the results of these examinations.